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    Functional Quality Specialist I

    Fortrea
    1-5 years
    Not Disclosed
    Pune
    15 June 7, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Fortrea Job Posting: Various Positions in Clinical Development

    Company Overview:

    Fortrea is a leading global contract research organization (CRO) dedicated to scientific rigor and clinical development excellence. Serving pharmaceutical, biotechnology, and medical device clients, Fortrea offers comprehensive clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff in more than 90 countries, we are transforming drug and device development for partners and patients worldwide.

    Key Responsibilities:

    1. Adverse Events and Product Quality Management:

      • Manage and review expeditable adverse events, product quality complaints, and medical information.
      • Submit reports to clients and regulatory agencies within agreed timelines.

    2. Process Review and Audit Readiness:

      • Assist in process reviews and measure/monitor audit readiness.
      • Coordinate client or external audits of assigned projects.

    3. Training and Development:

      • Design and track training schedules and materials for new hires and existing team members.

    4. Quality Management:

      • Contribute to quality error discussions and process improvements.
      • Assist in developing Quality Management Plans for assigned projects.
      • Support clients during regulatory inspections with the project team.

    5. Data Analysis and Process Improvement:

      • Perform and review data analysis to suggest and drive process improvements.
      • Track various types of information and metrics, conduct ongoing QC of defined process steps, and reconcile data from multiple sources.

    6. Medical Information Queries:

      • Respond to medical information queries, product quality complaints, and general queries received via telephone, email, fax, etc.
      • Review recorded information and execute drug safety data management processes.

    7. Safety Data Management:

      • Guide safety associates in managing voice calls as required.
      • Review and drive strategies for process improvement/excellence.

    8. Regulatory Submissions:

      • Review safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging Reports, Investigator Brochures, Clinical Study Reports, etc.

    9. General Support Activities:

      • Perform additional support activities as assigned.

    Who We Are Seeking:

    Fortrea is looking for motivated problem-solvers and creative thinkers who are passionate about overcoming barriers in clinical trials. We are committed to revolutionizing the development process to deliver life-changing ideas and therapies swiftly to patients in need.

    Why Join Fortrea:

    • Embrace a collaborative workspace that nurtures personal growth.
    • Make a meaningful global impact in clinical development.
    • Join an exceptional team dedicated to innovation and excellence.

    Equal Opportunity Employment:

    Fortrea is an Equal Opportunity Employer (EOE/AA). We strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without regard to race, religion, color, national origin, gender, family or parental status, marital status, sexual orientation, gender identity, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all qualified individuals to apply.

    For more information about Fortrea and to apply, visit Fortrea Careers.

    Privacy Statement:

    For information on how we collect and store your personal data, please see our Privacy Statement.

     

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